109th Congress

Cloning

Background

Since 1997 when researchers in Scotland successfully cloned Dolly, a sheep, the issue of human cloning has attracted considerable congressional and media interest. Periodic press reports on U.S. companies purportedly engaged in human cloning for either research or reproductive purposes have ensured continued interest in the issue on Capitol Hill. Bills to prohibit all forms of human cloning, including cloning to derive stem cells, passed by wide margins in both the 107th and 108th Congresses. These bills, both introduced by Representative Dave Weldon (R-FL), one of the few physicians in the House, received strong Administration support.

Reproductive cloning is generally defined as the use of cloning technology, also called somatic cell nuclear transfer (SCNT), for initiating a pregnancy; therapeutic cloning is generally defined as the use of SCNT for conducting research. SCNT is generally defined as transferring the nucleus of a human somatic cell (any cell other than an egg cell) to an egg cell from which the nucleus has been removed or rendered inert. Although most advocates and Members of Congress are opposed to reproductive cloning, there is considerable disagreement regarding therapeutic cloning. Proponents of therapeutic cloning argue that it may be one way of minimizing the immune system rejection problem that can result if the existing stem cell lines are used for clinical purposes. Therapeutic cloning would permit stem cells to be generated using a patient’s own DNA. Opponents argue that the moral and ethical issues related to creating an embryo solely for research purposes and subsequently destroying it to extract stem cells justify a ban on this technology.

When the 109th Congress convened, several cloning bills were reintroduced. Representative Weldon and Senator Sam Brownback (R-KS) continue to be the foremost opponents of all forms of human cloning. Arguing for a ban on only reproductive cloning are Senator Orrin G. Hatch (R-UT) and Representative Mary Bono (R-CA). Unlike prior Congresses, the House of Representatives did not pass any cloning legislation during the 109th Congress.

Provisions of the Legislation/Impact on NIH

Prohibited the expenditure of any Federal funds to conduct or support any research project that includes the use of human SCNT

Required the National Science Foundation to contract with the National Research Council to assess the impact that the implementation of this prohibition would have on research

H.R. 1357/S. 658—Human Cloning Prohibition Act of 2005

The bills, introduced by Representative Weldon and Senator Brownback, respectively, were largely similar. They would have:

Prohibited both reproductive and therapeutic cloning

Prohibited any person from knowingly 1) performing or attempting to perform human cloning, 2) participating in an attempt to perform human cloning, or 3) shipping or receiving for any purpose an embryo produced by human cloning or any product derived from such an embryo

Permitted other areas of scientific research, including research on the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans

Imposed civil and criminal penalties for violation of the provisions of the bill

S. 658 would have required the Government Accountability Office (GAO) to conduct a study on the use of new medical developments using SCNT and current public attitudes and prevailing ethical views concerning the use of SCNT. H.R. 1357 did not contain a similar provision.

S. 876 and H.R. 1822, introduced by Senator Hatch and Representative Bono, respectively, were similar but contained different reporting requirements.

S. 876 would have:

Prohibited only reproductive cloning

Made it unlawful to 1) conduct or attempt to conduct human cloning, 2) ship the product of nuclear transplantation (generally considered another term for SCNT) in interstate or foreign commerce for the purpose of human cloning in the United States or elsewhere, or 3) export to a foreign country an unfertilized blastocyst if the country does not prohibit human cloning

Required that all research involving nuclear transplantation be conducted in accordance with subpart A of 45 CFR 46. These provisions would have required, in part, review by an institutional review board (IRB) and appropriate informed consent.

Required GAO to review (within 1 year) the Attorney General’s enforcement record regarding the provisions of this bill as well as the manner in which the U.S. Department of Justice is coordinating the efforts of State Attorneys General and local law enforcement in enforcing similar State prohibitions. GAO would have also been required to provide a report on related laws adopted by foreign countries and the actions taken by those countries to enforce such laws.

Prohibited the maintenance of an unfertilized blastocyst for more than 14 days from its first cell division, not counting any time during which it was frozen

Prohibited the selling or receiving of human oocytes or unfertilized blastocysts for valuable consideration. Valuable consideration would not have included reasonable payments to compensate the donor for the time and inconvenience associated with the donation.

Prohibited nuclear transplantation from being conducted in a laboratory in which human oocytes are subject to assisted reproductive technology treatments or procedures

Imposed civil and criminal penalties for violation of the provisions of the bill

H.R. 1822 would have:

Prohibited only reproductive cloning

Made it unlawful to 1) conduct or attempt to conduct human cloning, 2) ship the product of nuclear transplantation (generally considered another term for SCNT) in interstate or foreign commerce for the purpose of human cloning in the United States or elsewhere, or 3) export to a foreign country an unfertilized blastocyst if the country does not prohibit human cloning

Required that all research involving nuclear transplantation be conducted in accordance with subpart A of 45 CFR 46. These provisions would have required, in part, review by an IRB and appropriate informed consent.

Required the Secretary of Health and Human Services to review (within 1 year) and report to Congress on efforts by the Food and Drug Administration to enforce a provision of the bill that would have required the forfeiture of property used to commit a violation of the bill. The Secretary would have also been required to report on efforts to coordinate enforcement of this provision with similar State laws. The U.S. Department of Health and Human Services would have been required to report on related laws adopted by foreign countries and the actions taken by those countries to enforce such laws.

Prohibited the maintenance of an unfertilized blastocyst for more than 14 days from its first cell division, not counting any time during which it was frozen

Prohibited the selling or receiving of human oocytes or unfertilized blastocysts for valuable consideration. Valuable consideration would not have included reasonable payments to compensate the donor for the time and inconvenience associated with the donation.

Prohibited nuclear transplantation from being conducted in a laboratory in which human oocytes are subject to assisted reproductive technology treatments or procedures

Imposed civil and criminal penalties for violation of the provisions of the bill

S. 1520/H.R. 3932—Human Cloning Ban Act of 2005

These bills were introduced by Senator Dianne Feinstein (D-CA) and Representative Bono, respectively. They were similar to S. 876 and H.R. 1822, except that the various reporting requirements had been removed. The bills would have:

Prohibited only reproductive cloning

Made it unlawful to 1) conduct or attempt to conduct human cloning, 2) ship the product of nuclear transplantation (generally considered another term for SCNT) in interstate or foreign commerce for the purpose of human cloning in the United States or elsewhere, or 3) export to a foreign country an unfertilized blastocyst if the country does not prohibit human cloning

Imposed civil and criminal penalties for violation of the provisions of the bill

Prohibited any Federal agency from awarding a grant, contract, or other payment to any individual, business, institution, or other organization that has engaged in human cloning within the past year or is under the control of an entity that has engaged in human cloning

Defined human cloning to include both reproductive cloning and the use of cloning technology to derive stem cells

Status and Outlook

H.R. 222 was introduced by Representative Stearns on January 4, 2005, and was referred to the House Committees on Science and on Energy and Commerce. No further action occurred on this legislation during the 109th Congress.

H.R. 1357, a companion bill to S. 658, was introduced by Representative Weldon on March 17, 2005, and was referred to the House Committee on the Judiciary. No further action occurred on this legislation during the 109th Congress.

S. 658, a companion bill to H.R. 1357, was introduced by Senator Brownback on March 17, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action occurred on this legislation during the 109th Congress.

S. 876, a companion bill to H.R. 1822, was introduced by Senator Hatch on April 21, 2005, and was referred to the Senate Committee on the Judiciary. No further action occurred on this legislation during the 109th Congress.

H.R. 1822, a companion bill to S. 876, was introduced by Representative Bono on April 26, 2005, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 109th Congress.

S. 1520, acompanion bill to H.R. 3932, was introduced by Senator Feinstein on July 27, 2005, and was referred to the Senate Committee on the Judiciary. No further action occurred on this legislation during the 109th Congress.

H.R. 3932, a companion bill to S. 1520, was introduced by Representative Bono on September 28, 2005, and was referred to the House Committee on the Judiciary. No further action occurred on this legislation during the 109th Congress.

H.R. 4118 was introduced by Representative Paul on October 20, 2005, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 109th Congress.